Process Manufacturing
SOPs, training and documentation for pharma manufacturers.
Procedures live in people's heads. Training records live in folders.
The Leak Assessment: 30 minutes, and a written plan within 48 hours, whether or not you hire us.
Cluxn helps pharmaceutical and API manufacturers with 50–500 employees document how they work: SOPs and work instructions written from the floor, staff training, documentation for Revised Schedule M readiness and export websites. We do not build validated GMP software. SOPs typically take 6 weeks, at a fixed price in writing after a 30-minute Leak Assessment.
Pharmaceuticals & API: common problems
What it's costing you.
Procedures Not Written Down
Core production steps live with experienced operators, so new staff learn by shadowing and each one learns it differently
Training Records Scattered
Who was trained on which procedure, and when, sits across registers and folders
Revision Control by Email
Procedure revisions circulate by email and printouts, so people work from different versions
Inspection Preparation Scramble
Documents are gathered by hand before every inspection instead of being kept ready
Standards and documents Pharmaceuticals & API buyers ask about
What buyers check.
Revised Schedule M (India)
The updated GMP requirements under the Drugs Rules. The extension for MSME units ended on 31 December 2025 and inspections have begun. Cluxn writes the SOPs and training records inspectors ask to see; it does not certify compliance.
SOPs and revision control
Inspectors and export buyers ask to see current, approved procedures and who was trained on each.
Export buyer qualification
Overseas buyers send supplier questionnaires and review your website and documents before ordering.
How Pharmaceuticals & API plants run, step by step
How the work flows.
- 1
Map current procedures
We walk the floor and QA office and list what is done, by whom, and what is written down.
- 2
Write SOPs and work instructions
Procedures are drafted from how the work is really done, in plain language.
- 3
QA review and approval
Your QA team reviews, edits and approves each document.
- 4
Train and record
Operators are trained and training is recorded against each procedure.
- 5
Revision control
Revisions are tracked so the floor works from the current version.
- 6
Export-ready website
A website presents your capabilities and documentation to overseas buyers.
KPIs we track for Pharmaceuticals & API manufacturers
What gets measured.
- Procedures due for review
- Training records complete by role
- Time to retrieve a document during an inspection
- Export buyer inquiries answered
Services for Pharmaceuticals & API manufacturers
The fix.
How it works
The Leak-First Method
Five steps, in this order.
Step 1
Find the leak
30-minute Leak Assessment
Step 2
Get the plan
Tasks and a fixed price in writing within 48 hours
Step 3
Fix it first
First working version in about 4 weeks
Step 4
Train and hand over
Your team trained; code, docs and logins are yours
Step 5
Next leak
Support, or the next fix on a monthly plan
Pharmaceuticals & API FAQs
Common questions.
No. We do not claim validated GMP software, 21 CFR Part 11 or GAMP 5 compliance. We write SOPs and work instructions, run training, and build documentation and export websites.
Step 1 of The Leak-First Method
See it built for pharmaceuticals & api.
We will show you the first fix and what it costs. No pitch.
The Leak Assessment: 30 minutes, and a written plan within 48 hours, whether or not you hire us.
Find the leak
30-minute Leak Assessment
Get the plan
Tasks and a fixed price in writing within 48 hours
Fix it first
First working version in about 4 weeks
Train and hand over
Your team trained; code, docs and logins are yours
Next leak
Support, or the next fix on a monthly plan
Every project includes
- 30-minute Leak Assessment
- Written plan within 48 hours
- Fixed scope and price in writing
- Weekly demos
- Your team trained before go-live
- Code, documents and logins handed over
- Support after go-live
- Written exit clause, no license fees